MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-11 for EVARREST FIBRIN SEALANT PATCH manufactured by Omrix Biopharmaceuticals Ltd.
[65038905]
This was a spontaneous report from a physician via a sales representative and concerns a patient of unspecified age and sex from the united states: (b)(6). The patient's height, weight and medical history were not reported. The patient was treated with evarrest fibrin sealant patch (batch t10f282a) initiated on (b)(6) 2016 for hemostasis during an open abdominal aortic aneurysm. Concomitant medications were not reported. It was reported by the sales rep that during an open abdominal aortic aneurysm repair that same date, the device did not stop the bleeding (lack of efficacy). Two surgiflo and one surgicel were used to stop the bleeding and complete the procedure (bleeding). The patient received an unspecified number of transfusions (details unspecified). It is unknown if there was a change to post operative care. Action taken with evarrest fibrin sealant patch was not applicable. The patient outcome was unknown for lack of efficacy (serious) and bleeding (serious). A product quality complaint is associated with this report. No device will be returned. This report was serious (medically significant) and reportable (malfunction). This case is linked to drug/device case (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[65045053]
Additional information was received from the sales representative on (b)(6) 2016. The customer did not allege that there was a deficiency with either surgiflo or surgicel. Surgicel was used throughout the procedure before and after use of fibrin sealant patch. The fibrin sealant patch was used with surgicel create hemostasis on the aorta. The current status medical history and demographics of the patient were unknown, but it was reported that the patient was on plavix (clopidogrel bisulfate) during the procedure.
Patient Sequence No: 1, Text Type: D, B5
[66031127]
Additional information was received from ethicon qa (quality assurance) on (b)(6) 2017 and from mso (medical safety officer) on (b)(6) 2017. Additional batch number (b)(4) was added. The suspected product quality complaint (pqc) associated with adverse event lack of efficacy has been confirmed to be product meets specifications based on the pqc evaluation/investigation performed.
Patient Sequence No: 1, Text Type: D, B5
[67330205]
Additional information was received from (b)(6) on (b)(6) 2017. Additional batch number (bac ii fibrinogen component) t34c510 was added. The suspected product quality complaint (pqc) associated with adverse event lack of efficacy has been confirmed to be product meets specifications based on the pqc evaluation/investigation performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2016-01248 |
| MDR Report Key | 6242760 |
| Date Received | 2017-01-11 |
| Date of Report | 2017-01-26 |
| Date of Event | 2016-12-21 |
| Date Mfgr Received | 2016-12-22 |
| Date Added to Maude | 2017-01-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | US ROUTE 22 |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082180707 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVARREST FIBRIN SEALANT PATCH |
| Generic Name | OTHER |
| Product Code | MZM |
| Date Received | 2017-01-11 |
| Lot Number | T10F282A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OMRIX BIOPHARMACEUTICALS LTD |
| Manufacturer Address | TEL HASHOMER, IS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-11 |